Recall Z-1514-2025— Ethicon Endo Surgery, LLC
Class II · Ongoing
Class II FDA medical device recall by Ethicon Endo Surgery, LLC, initiated 2025-03-07. FDA's recall record names no specific 510(k) clearance for this event. Product: PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1. Reason: Identified curing issues with the silicone during the needles manufacturing process..
- Recalling firm
- Ethicon Endo Surgery, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-07
- Firm location
- Guaynabo, PR, United States
Product description
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Reason for recall
Identified curing issues with the silicone during the needles manufacturing process.
Data sourced from openFDA. This site is unofficial and independent of the FDA.